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Viaskin Milk · 1 trial · 1 indication
A treatment responder is defined as a subject who meets at least one of the following criteria: * A ≥10-fold increase in the Cumulative Reactive Dose (CRD) of cow's milk proteins at the Month 12 double-blind placebo-controlled food challenge (DBPCFC) as compared to baseline value and reaching at least 144 mg of cow's milk proteins; * A CRD of cow's milk proteins ≥1444 mg at the Month 12 DBPCFC.
| Arm | Type | Description |
|---|---|---|
| Viaskin Milk 150 mcg | EXPERIMENTAL | One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months. |
| Viaskin Milk 300 mcg | EXPERIMENTAL | One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months. |
| Viaskin Milk 500 mcg | EXPERIMENTAL | One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months. |
| Viaskin Placebo | PLACEBO_COMPARATOR | One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months. |
| Name | Type | Description |
|---|---|---|
| Viaskin Milk 150 mcg | BIOLOGICAL | Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins. |
| Viaskin Milk 300 mcg | BIOLOGICAL | Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins. |
| Viaskin Milk 500 mcg | BIOLOGICAL | Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins. |
| Viaskin Placebo | BIOLOGICAL | Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation. |
Eligibility criteria for study enrollment: Inclusion Criteria: * Signed Informed Consent Form (ICF) by parent(s)/guardian(s) of subjects and informed assent form (IAF) for subjects ≥7 years, or as per local or country specific guidelines or regulations. * Male or female subjects 2 to 17 years old ...
Viaskin Milk is an investigational immunotherapy developed by DBV Technologies S.A. (ticker DBVT) for food allergy, specifically IgE-mediated cow's milk allergy. It is a Phase 1 product candidate and is also known as Viaskin Milk 150 mcg. It has been studied in a single completed clinical trial.
Viaskin Milk is being developed for food allergy, with its completed trial enrolling children with IgE-mediated cow's milk allergy. The study population was children aged 2 years and older, and participants were not healthy volunteers. It is investigational and has not been approved for commercial use.
Viaskin Milk is developed by DBV Technologies S.A., which trades under the ticker DBVT. The company sponsored the clinical program evaluating the candidate in children with IgE-mediated cow's milk allergy across sites in the United States and Canada.
Viaskin Milk is in Phase 1 development. Its only listed trial, NCT02223182, is a completed Phase 1 study, and there are currently no active trials of the candidate. It remains investigational and has not been approved by the FDA.
Viaskin Milk has been studied in one completed trial, NCT02223182, titled "Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy." The Phase 1 study enrolled 198 participants, was randomized, double-blind, and placebo-controlled, and ran in the United States and Canada.